Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT01355835
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Age: between 18 and 80 years
* Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms and therapy with STN-DBS (ACTIVA pulse generators) at least six months from surgery
* Optimized subthalamic stimulation at study enrolment (refer 'treatment' section)
* Gait disturbance refractory on best individual STN-DBS (STNmono) and dopaminergic therapy: 'gait score' in the best clinical \[MedOn/STNmono\] condition ≥ 12
* Clinical and image-guided (and facultatively electrophysiological) confirmation of (i) one of the two rostral contacts of the quadripolar electrode localized in the STN area, and (ii) the caudal contacts in the border zone of STN and SNr.
* Dopaminergic medication constant for at least four weeks prior to study enrolment
* Disease duration ≥ 5 years
Exclusion Criteria:
* Cognitive impairment (Mini Mental State Exam \< 25)
* Participation in other clinical trials within the past three months and during enrolment in our study
* Suicidality, Psychosis
* Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
* Pregnancy
* Acute adverse events from stimulation on contacts in the caudal STN / SNr border interfering with the intended stimulation protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01355835
Study Brief:
Protocol Section:
NCT01355835